A Trial of Two Daclizumab Dosing Strategies vs. No Induction Treatment With Tacrolimus, Mycopheno… (NCT00363116) | Clinical Trial Compass
CompletedPhase 4
A Trial of Two Daclizumab Dosing Strategies vs. No Induction Treatment With Tacrolimus, Mycophenolate Mofetil , & Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
United States298 participantsStarted 1999-04
Plain-language summary
The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Simultaneous kidney/pancreas transplant recipients
* Insulin dependent Type 1 or 2 diabetes pretransplant
* Recipient age 18-65 years
* Donor age 5-65 years
* Women must have negative serum pregnancy test and practice birth control for study duration
* Negative T-cell crossmatch
* Parent (or guardian) is able to understand the consent form and give written informed consent
Exclusion Criteria:
* Prior treatment with daclizumab
* Known sensitivity or contraindication to tacrolimus, MMF, or steroids
* Patient with significant or active infection
* Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
* Patients whose life expectancy is severely limited by diseases other than renal disease
* Ongoing substance abuse, drug or alcohol
* Major ongoing psychiatric illness or recent history of noncompliance
* Insufficient cardiovascular reserve
* Malignancy within last 5 years, excluding nonmelanoma skin cancers
* Serologic evidence of infection with HIV or Hepatitis B surface antigen positive
* Investigational drug within 30 days prior to transplant surgery
* Anti-T cell therapy within 30 days prior to transplant surgery
What they're measuring
1
To assess the incidence of presumed acute kidney or pancreas rejection, death, and kidney or pancreas graft loss in the first 6 months post transplant.